ASA Adjudication on Fast Systems Ltd

Ad

A national press ad, for the SnoreWizard device, was headlined “Stop snoring or your money back!” Text stated “It’s simple, fast and effective - best of all it’s covered by our full money back guarantee”.

Issue

The complainant, who believed the device was unlikely to have the same effect on all users, challenged whether it worked as claimed.

CAP Code (Edition 11)

Response

Fast Systems said the ad did not claim that the device would have the same effect on all users.  They pointed out that under the heading "The permanent solution for you?" the ad made specific mention of conditions that would make a Snorewizard unsuitable.  They added that it was generally known that that type of device did not work for everyone, and they therefore offered a money-back guarantee to ensure satisfaction.  They offered to provide audited evidence to prove that they did refund to customers who required it, and that their success rate was around 85%.

Fast Systems said Snorewizard and similar products were not classified as medical devices under the European CE marking system.  They sent a CE exemption certificate and a letter from the Medicines and Healthcare products Regulatory Agency (MHRA).  They argued that many products did not work in the way advertised nor produce the results indicated for all.  However, Fast Systems believed they could demonstrate that Snorewizard would work for most people outside the categories specifically exempted in the ad.  They said, before marketing the product, they had considered conducting a clinical trial but had not been able to find a suitable or practical route. However, they had sought advice from experts who suggested that the sheer weight of published literature about such devices, which could reasonably be described as generic, would be more than adequate to support the claims.  Fast Systems sent statements from two experts and a study mentioned by one of the experts.  

The first statement was from a dental technician who had manufactured and supplied custom-made anti-snoring devices to dentists for about nine years.  He explained that mandibular advancement devices increased the vertical opening and moved the lower jaw forward fractionally, and thus increased the air passage at the soft palate at the back of the throat, which was the cause of much snoring.  He said many snorers could not afford a custom-made solution and there were therefore many other mandibular advancement devices on the market such as Snorewizard.  He had advised Fast Systems on its design and effectiveness, and, after changes had been made following his advice, was satisfied that it was an effective anti-snoring device.  He said it was supplied in single-size, semi-soft plastic and was therefore not securely fitting and might not be as comfortable as a custom-made device. Nevertheless, he pointed out that it used the same principle and believed that the Snorewizard was an effective solution as a single-size product, and understood that it achieved an 85% success rate, which was very much what he would expect.  

The second statement was from a professor of Respiratory Medicine and consultant physician at the Oxford Sleep Unit, who had been involved in both the clinical and research aspects of sleep, sleep apnoea and snoring for over 25 years, and had published over 200 articles in scientific journals on those subjects.  He said the use of dental devices to control snoring and sleep apnoea had been extensively reviewed in recent meta-analyses, which all concluded that dental devices did work in reducing sleep apnoea and snoring.  He said there were virtually no head-to-head comparisons of different dental devices and they all seemed to perform similarly.  He explained that the main factor that influenced technical success seemed to be the extent to which the device held the lower jaw forwards, and other factors included comfort, and thus tolerability, and whether the device was retained in its proper location or fell out during sleep.  He added that all the reviews concluded that it was not possible to accurately predict who would respond to dental devices and who would not, and although there were general factors that reduced efficacy, such as degree of obesity and severity of sleep apnoea, they were not precise enough to predict success in individual cases.

The consultant said, because there was clear evidence that dental devices did work in many people, he recommended to patients with snoring and mild sleep apnoea that they should consider a dental device.  He said Snorewizard advanced the lower jaw and would be predicted to work on that basis alone, and that when he first used the device and began to recommend it to patients, he had had concerns that it would not be properly retained in the correct position overnight, but had found that retention was surprisingly good in most cases.  His experience was that the device worked well in most people but not all, as was the case for any dental device, regardless of its sophistication, and there was no reason to think that it was less effective than other such devices.

Assessment

Not upheld

The ASA noted the two experts consulted by Fast Systems believed Snorewizard was an effective anti-snoring device for most people, based on the principle of mandibular advancement.  We also noted they referred to clinical studies that indicated that dental devices were likely to improve snoring and sleep-disordered breathing.  We noted the studies had not tested the device advertised, but noted the experts believed all devices of that type would have a similar effect, although we understood that there would inevitably be some patients for whom the device would not work.  We considered, however, that readers would be unlikely to assume from the claim and the headline that the product would work for everyone, and would understand from the ad that some conditions would limit effectiveness and that they could obtain a refund if it was not effective for them.  We concluded that the ad was unlikely to mislead.   

We investigated the ad under CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health & Beauty products and therapies) but did not find it in breach.

Action

No further action necessary.

Adjudication of the ASA Council (Non-broadcast)